The following data is part of a premarket notification filed by Ansell Intl. with the FDA for Sensiderm.
Device ID | K904244 |
510k Number | K904244 |
Device Name: | SENSIDERM |
Classification | Surgeon's Gloves |
Applicant | ANSELL INTL. LOT 80, AIR KEROH IND. EST. Melaka, MT 75150 |
Contact | Paul Cacioli |
Correspondent | Paul Cacioli ANSELL INTL. LOT 80, AIR KEROH IND. EST. Melaka, MT 75150 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-14 |
Decision Date | 1991-02-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SENSIDERM 79119888 4427082 Live/Registered |
Electrophoretics Limited 2012-07-03 |
SENSIDERM 73178907 1115116 Dead/Cancelled |
PPRL, INC. 1978-07-20 |